JPRN-jRCTs041200080招募中1 期
A placebo-controlled, randomized, double-blind study to evaluate the efficacy of Cistanche herb extract for cervical spondylotic myelopathy
Kawaguchi Yoshiharu0 个研究点目标入组 50 人开始时间: 2020年12月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 <= 85age old(—)
- 性别
- All
入选标准
- •1) Those whose age at consent date is 40 years - 85 years.
- •2) Those who can participate in the inspection conducted on the University of Toyama Sugitani Campus.
- •3) Those who meet the diagnostic criteria for cervical spondylotic myelopathy by physical examination.
- •4) Those who have a cervical spine JOA score of 8 points or more and 15 points or less at the time of screening.
- •5) Those who agree to provide blood samples for clinical examination.
- •6) The person can take the test drug, and the person or family member can manage to intake the drug.
- •7) Those who agree not to make extreme changes in lifestyle such as exercise habits and eating habits
- •during the test period.
排除标准
- •1) Patients who do not agree.
- •2) Those who was in uncontrolled and clinically problematic health conditions (diabetes, hypertension,
- •thyroid / endocrine disorders, congestive heart failure, angina, heart disease, cancer risk such as breast
- •cancer, uterine cancer, or ovarian cancer, gastrointestinal disease, dialysis or renal dysfunction, etc.) within 3 months of consent.
- •3) Those with a history of alcohol and substance abuse.
- •4) Those who are participating in other intervention clinical trials.
- •5) Those with a cervical spinal cord JOA score of 16 points or more at the time of screening and very mild
- •cervical spondylotic myelopathy.
- •6) Those who have a cervical spinal cord JOA score of 7 points or less at the time of screening and who
- •have serious cervical spondylotic myelopathy and who are judged to require early surgery.
- •7) In addition, those who are judged by the researcher to be inappropriate as subjects.
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